Graz, Austria incl. Pilot Plant

Manufacturing Site

Our manufacturing facility in Graz offers expertise in aseptic production, a diverse portfolio of high-end products, a wide variety of container options with flexible production configurations, and a comprehensive service package from first feasibility studies to approval strategies worldwide. Graz has a special position within the Fresenius Kabi network as a center of competence for aseptic production of liquid pharmaceuticals. Aseptic filling at the Graz plant began almost 30 years ago, which reflects our track record of expertise and experience. The plant meets top quality standards and has a high level of automation, but also has the flexibility to deal with very specific customer demands. The plant has seen several significant upgrades and expansions in recent years. State-of-the art aseptic filling lines for bags and vials for small volume parenterals (2 ml-50 ml) and glass filling line for large volume parenterals are only some of the features of this manufacturting site. In Graz we have also the possibility of filling syringes. Pre-filled syringes are safer and quicker to use than ampoules and vials. They also waste less product, making them a container of choice for valuable products such as protein drugs. These advantages are reason enough for the Graz plant to move into the pre-filled syringe market. Our ambition in Graz is to always be on top of the latest developments, so that we can handle complex products and processes confidently.

Pilot Plant

The Pilot Plant of Fresenius Kabi Austria in Graz offers expertise in manufacturing clinical batches of sterile pharmaceuticals. Due to the regulatory approval by major authorities (FDA & EMEA), the Pilot Plant Graz has become an important manufacturing site for global clinical studies. The flexible setup of the compounding and filling line allows manufacturing of various sterile pharmaceuticals in a range of container closure systems meeting the demands during the clinical trial phases II/III. The Pilot Plant in Graz, Austria and its affiliated analytical laboratory were built in 2004 as an extension of the already existing commercial plant in Graz. While using synergies with the commercial plant, such as common supply for hot purified water and nitrogen, the Pilot Plant Graz offers a higher degree of flexibility for manufacturing GMP batches due to a more manual setup than our highly automated commercial plants. This flexibility enables us to fill multiple container closure systems from a single bulk solution for testing multiple containers during the clinical phase, while saving costs and time for the clinical study. Besides manufacturing complex aqueous solutions, the Pilot Plant is also equipped with various homogenizers for manufacturing emulsions, liposomal formulations and suspensions from 5 L to 1000 L. The freely programmable autoclave in place includes the option for rotating cycles, meeting the special sterilization needs for various formulations. For high-potent APIs, a special pharma lab was commissioned in 2008 in order to develop and manufacture pharmaceuticals with APIs up to an OEL level of 4. A team of highly trained engineers and scientists offers their services to implement your product in the Pilot Plant and also supports with the scale-up starting with a lab-scale batch up to 1000L. Sophisticated developmental assays help us to optimize process parameters to guarantee a smooth scale-up and consistent product quality following the Quality by Design (QbD) guideline. Once the product successfully passed the clinical study, a dedicated project team will coordinate the transfer of the product to one of our commercial plants, taking advantage of the experience and knowledge of the manufacturing process gained during the clinical phase.

Technologies:

  • Batch sizes: 5L to 1000L
  • Secondary and blinding of study medication for clinical studies in cooperation with the plant Neufahrn
  • Oxygen-controlled filling
  • Compounding of complex aqueous solutions, fat emulsions, liposomal formulations and suspensions
  • Static and rotating terminal sterilization
  • Aseptic processing in cooperation with the commercial plant Graz
  • Lyophilization in cooperation with commercial plant Graz

Products:

  • Infusion solutions such as anesthetics, analgesics and antibiotics (non beta-lactams)
  • Parenteral nutrition products
  • Medical devices and diagnostic products, such as irrigation solutions, X-ray contrast agents

Containers:

  • Glass vials and bottles (3 ml-1000 ml)
  • COC vials and bottles (3 ml-1000 ml)
  • Freeflex bags (50 ml-3000 ml)
  • Glass and plastic pre-filled syringes done in cooperation with commercial plant (0,5 ml-50 ml)

Certificates:

  • FDA
  • EMEA
  • ISO 9001
  • ISO 14001

Market:

  • Worldwide